Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Adherence to the Multicomponent Telehealth Intervention
研究概览
简要总结
The aims of this study are to determine the feasibility and acceptability of a multicomponent telerehabilitation program for medically complex older Veterans and to preliminarily assess participant outcomes (physical activity, physical function, quality of life, loneliness) to the program.
详细描述
The aims of this study are to determine the feasibility and acceptability of the multicomponent telerehabilitation program and to preliminarily assess participant outcomes. The multicomponent program/intervention consists of 3 core components: 1) high-intensity rehabilitation interventions, 2) biobehavioral interventions, and 3) social support. The delivery of the program is supported by various technologies allowing for synchronous and asynchronous care and monitoring. Synchronous telerehabilitation will occur individually and in virtual groups. Feasibility and acceptability will be assessed by Veteran adherence to program components and validated surveys. Preliminary responsiveness will be assessed primarily by change in 7-day average step count and secondarily by other physical function tests and patient reported outcome measures. Study findings will have immediate clinical impact as they will guide implementation of safe and effective telerehabilitation strategies for medically complex older Veterans who lack access to standard in-person rehabilitation services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to group allocation
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years of age and older
- •Multiple chronic conditions (Charlson Comorbidity Index 3)
- •Impaired physical function (< or = 10 repetitions on 30 second sit to stand test)
排除标准
- •Life expectancy < 12 months
- •Acute or progressive neurological disorder (e.g. Amyotrophic Lateral Sclerosis, recent stroke)
- •Moderate to severe dementia without caregiver assistance (< 18 on telephone Montreal Cognitive Assessment (MoCA Blind)
- •Unstable medical condition precluding safe participation in progressive rehabilitation (e.g. unstable angina)
结局指标
主要结局
Adherence to the Multicomponent Telehealth Intervention
时间窗: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Adherence will be calculated as the proportion of the number of sessions attended out of the number prescribed per protocol (32 sessions)
次要结局
- Physical Activity(Change from pre-program (baseline for Group 1, 12 weeks for Group 2) to post-program (12 weeks for Group 1, 24 weeks for Group 2).)
- Feasibility of the Multicomponent Telehealth Intervention(Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2))
- Acceptability of the Multicomponent Telehealth Intervention(Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2))
- Participant Recruitment(Baseline)
- Satisfaction of the Multicomponent Telehealth Intervention(Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2))
- Safety Event Count(Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2))
- Exercise Stages of Change Questionnaire(Change from Baseline to 12 weeks)
- Self-efficacy for Exercise (SEE) Scale(Change from Baseline to 12 weeks)
- 30 Second Sit to Stand(Change from Baseline to 12 weeks)
- Arm Curl Test(Change from Baseline to 12 weeks)
- 2-minute Step Test(Change from Baseline to 12 weeks)
- Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form(Change from Baseline to 12 weeks)
- 3-Item Loneliness Scale(Change from Baseline to 12 weeks)
- PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only(Change from Baseline to 12 weeks)
- Participant Retention(12 Weeks and 24 Weeks)